二陈汤合萆薢分清饮治疗急性脑梗死伴高尿酸血症痰瘀阻络证患者的临床疗效

Clinical Effect of Erchentang and Bixie Fenqingyin Combined on Patients with Acute Cerebral Infarction with Hyperuricemia with Syndrome of Phlegm and Blood Stasis Blocking Collaterals

目的:探讨二陈汤合萆薢分清饮治疗急性脑梗死伴高尿酸血症痰瘀阻络证患者的临床疗效及安全性,拟为急性脑梗死伴高尿酸血症的治疗提供新的方法和依据。方法:选取上海中医药大学附属普陀医院2021年5月—2022年5月符合标准的急性脑梗死伴高尿酸血症痰瘀阻络证患者132例,随机分为中药组、西药组及对照组(每组各44例)。3组均予以急性脑梗死西医常规疗法,中药组在此基础上服用二陈汤合萆薢分清饮,西药组在此基础上服用苯溴马隆片,对照组则不予以任何降尿酸治疗,治疗疗程为4周。通过观察患者发病3个月后改良Rankin量表(mRS)评分及治疗前后的美国国立卫生研究院卒中量表(NIHSS)评分、中医证候积分、血尿酸(SUA)水平、血清C反应蛋白(CRP)和白细胞介素-6(IL-6)水平、血清超氧化物歧化酶(SOD)和丙二醛(MDA)水平及其他安全性指标。结果:最终完成试验观察病例129例,中药组43例,西药组42例,对照组44例。中药组预后良好率(83.7%,36/43)优于西药组(64.3%,27/42)及对照组(40.9%,18/44)(χ^(2)=4.184,16.930,P<0.05),西药组优于对照组(χ^(2)=4.70,P<0.05)。治疗后3组患者NIHSS评分、中医证候积分、SUA、CRP、IL-6、MDA水平均较治疗前降低,SOD水平升高(P<0.05)。其中,中药组和西药组NIHSS评分改善程度均优于对照组(P<0.05);中药组中医证候改善程度最优(P<0.05);西药组降尿酸程度最优(P<0.05)。3组治疗前后各项安全性指标均未出现明显异常,未见严重不良反应。结论:二陈汤合萆薢分清饮治疗能显著改善急性脑梗死伴高尿酸血症痰瘀阻络证患者的预后、早期神经功能缺损及中医证候,降低血尿酸水平,抑制炎症反应及氧化应激反应。

Objective:To explore the clinical efficacy and safety of the combination of Erchentang and Bixie Fenqingyin in the treatment of patients with acute cerebral infarction accompanied by hyperuricemia of phlegm and blood stasis blocking collaterals syndrome to provide a new method and evidence for the treatment of acute cerebral infarction with hyperuricemia.Method:A total of 132 eligible patients with acute cerebral infarction accompanied by hyperuricemia of phlegm and blood stasis blocking collaterals syndrome admitted to the Putuo Hospital of Shanghai University of Traditional Chinese Medicine(TCM)from May 2021 to May 2022 were randomly divided into a Chinese medicine group,a western medicine group,and a control group,with 44 cases in each group.All three groups received routine western medical treatment for acute cerebral infarction.Additionally,the Chinese medicine group received Erchentang combined with Bixie Fenqingyin,the western medicine group received Benzbromarone tablets,and the control group did not receive any uric acid-lowering treatment.The treatment duration was four weeks.The modified Rankin Scale(mRS)score after three months of onset,as well as the National Institutes of Health Stroke Scale(NIHSS)scores,TCM syndrome scores,serum uric acid(SUA)levels,serum C-reactive protein(CRP)and interleukin-6(IL-6)levels,serum superoxide dismutase(SOD)and malondialdehyde(MDA)levels,and other safety indicators were observed before and after treatment.Result:A total of 129 cases completed the trial observation,with 43 cases in the Chinese medicine group,42 cases in the western medicine group,and 44 cases in the control group.The rate of good prognosis in the Chinese medicine group(83.7%,36/43)was higher than that in the western medicine group(64.3%,27/42)and the control group(40.9%,18/44)(χ^(2)=4.184,16.930,P<0.05),and the western medicine group was superior to the control group(χ^(2)=4.707,P<0.05).After treatment,the NIHSS scores,TCM syndrome scores,SUA,CRP,IL-6,and MDA levels of the patients in all three groups decreased,while the SOD levels increased compared with those before treatment(P<0.05).Among them,the improvement in NIHSS score was better in the Chinese medicine group and the western medicine group than in the control group(P<0.05).The Chinese medicine group showed the greatest improvement in TCM syndrome(P<0.05),while the western medicine group showed the greatest reduction in uric acid levels(P<0.05).No significant abnormalities in safety indicators were observed before and after treatment in the three groups,and no serious adverse reactions were reported.Conclusion:The combination of Erchentang and Bixie Fenqingyin can significantly improve the prognosis,early neurological deficits,and TCM syndromes of patients acute cerebral infarction accompanied by hyperuricemia of phlegm and blood stasis blocking collaterals syndrome.It can also lower uric acid levels and inhibit inflammatory and oxidative stress reactions.